Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Dementia, Alzheimer's, Rivastigmine, donepezil
Eligibility Criteria
Inclusion Criteria:
- Be at least 50 years of age;
- Have a diagnosis of probable Alzheimer's Disease;
- Have an MMSE score of > or = 10 and < or = 24;
- Must have a caregiver who is able to attend all study visits;
- Have received continuous treatment with donepezil for at least 6 months prior to screening, and received a stable dose of 5 mg/day or 10 mg/day for at least the last 3 of these 6 months.
Exclusion Criteria:
- Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
- Have a history of malignancy of any organ system, treated or untreated, within the past 5 years;
- Have a history within the past year or current diagnosis of cerebrovascular disease;
- Have a current diagnosis of severe or unstable cardiovascular disease; Have a history of myocardial infarction (MI) in the last six months;
- Severe or unstable respiratory conditions (e.g., severe asthma , severe pulmonary (lung) disease);
- Digestive problems related to peptic ulcer;
- Urinary obstruction or current severe urinary tract infection;
- Abnormal thyroid function tests;
- Low folate or Vitamin B12;
- Have a disability that may prevent the patient from completing all study requirements;
- Have a current diagnosis of an active skin lesion/disorder that would prevent adhesion of a patch;
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Dedicated Clinical Research
- ATP Clinical Research
- Margolin Brain Institute
- Investigative site
- Berma Research Group
- Sunrise Clinical Research
- Center for Clinical Trials
- Premiere Research Institute @ Palm Beach Neurology
- Medical Associates of North Georgia
- Medical Associates of North Georgia
- Witham Health Services
- Investigative site
- Rochester Center For Behavioral Medicine
- Alzheimer's Research Corporation
- Investigative site
- Neurobehavioral Research, Inc
- Eastside Comprehensive Medical Center
- Investigative site
- The Ohio State University
- Investigative site
- The Clinical Trial Center
- Senior Adults Specialty Research
- Investigative site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Immediate Switch
Delayed Switch
Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.